FDA Issues Revised Guidance on Hospital and Healthcare Systems Compounding

Today, the FDA issued a third revision of a draft guidance titled Hospital and Health System Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act (here).  The Agency revised this guidance, which was previously revised in June 2016, in response to comments submitted to that document.  The revised document describes how and […]

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Annual Medicines for Europe and IGBA Conference

The Key Role of Off Patent Medicines: Fran Zipp, President and CEO of Lachman Consultant Services, Inc., will be a moderator on Session- 6 OFF-PATENT ROLE FOR GLOBAL HEALTH: PUTTING PATIENTS FIRST, at the Annual Medicines for Europe and IGBA Conference in Athens, Greece on October 6-8, 2021. The agenda includes bridging the access gap […]

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Lachman Consultants Named “Top-Ten Medical Device Consulting Company” by Med-Tech Outlook

(Westbury, NY— November 2020) Lachman Consultant Services, Inc. (Lachman Consultants), a provider of compliance, regulatory, and technical consulting services to the global pharmaceutical and related industries, was recently named a “Top-Ten Medical Device Consulting Company” by highly-regarded, industry publication MedTech Outlook. In making the announcement in its September issue, the monthly periodical outlined that its […]

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Rebecca (Becky) Welton, new Senior Associate in the Regulatory Practice at Lachman Consultants

We are pleased to announce that Rebecca Welton has accepted the position of Senior Associate in the Regulatory Practice at Lachman Consultants, effective August 3, 2020. Ms. Welton is an experienced Science, Operations and Regulatory leader with 25+ years in the pharmaceutical industry, holding positions of escalating accountabilities in chemistry, formulation, management, pilot plant, and […]

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FDA Grants EUA for Remdesivir

No, this is not an approval, but it is an emergency use authorization to use the antiviral Remdesivir for COVID 19 patients.  The FDA issued this EUA on Friday, in record time, after positive results of the study involving Gilead’s drug.  The EUA will remain in effect until the COVID 19 public health emergency is […]

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March 2020 Approval Actions, CRLs and Receipts and Update on Feb Metrics

Today OGD provided partial information for the typical first reported March Metrics and updated its February 2020 metrics.  Let’s start with the new March data. OGD reports 60 full approval actions and 17 tentative approval actions for a total of 77 approval actions for original applications in March, which is the highest number of total […]

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